Applied Clinical Trials, Feb 1, 2013 - Applied Clinical Trials

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Applied Clinical Trials, Feb 1, 2013
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News
Central Lab Review Prevent Underpowered Studies
By Tim Callahan
The sponsor of a recent Phase II global study, conducted at more than 50 sites, invested in a centralized digital pathology core lab to ensure a homogenous and representative study population.
FDA Speeds More Breakthrough Drugs to Market
By Jill Wechsler
The Food and Drug Administration approved nearly 40 new drugs in 2012, beating most recent totals, and is looking for provisions of the FDA Safety & Innovation Act (FDASIA) to further improve its operations and encourage innovation.
Medicare and the NCD
By Jim Moran , Erika Stevens , Julie Statzel
While there is no single correct way to develop process compliance controls to meet federal clinical trials billing regulations around Medicare, standardization of the entire billing process is key.
Regulatory Landscape Changes in Russia
By Philip Ward
Russian regulators have reportedly implemented the much awaited changes to the nation's regulatory process for medical devices, and the revised regulations took effect at the start of January.
View from Brussels
Bringing Brussels and Africa Closer on Trials
By Peter O'Donnell
Researchers from sub-Saharan countries are going to have better chances of upgrading their skills.
CTI Insights
Cutting Our Losses in Translation
By Wayne R. Kubick
To reduce the time from bench to bedside we need to transform competition into cooperation.
Feature Article
Clinical Trials in the Baltic States
By Donatas Grina , Indre Tutlyte , Audrius Sveikata
The region has an appropriate population size, solid infrastructure, experienced nvestigators, and short timelines.
DIY EDC Evaluation
By Timothy Pratt
Options have emerged that make DIY EDC technology more accessible to smaller organizations.
Business News
Business and People
By Hannah Becker
Options have emerged that make DIY EDC technology more accessible to smaller organizations.
A Closing Thought
Three Steps to Better Decisions
By Kevin Connor
Decision makers can increase collaboration, transparency, efficiency, and effectiveness, while reducing development risks.

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